Biolegam 100/60 mg 8 tablets

Available at Pharmaegy Pharmacy. Use as directed by your doctor.

Biolegam 100/60 mg 8 tablets Composition: Each film-coated tablet contains: -Sildenafil citrate equivalent to 100 mg Sildenafil -Dapoxetine hydrochloride equivalent to 60 mg Dapoxetine. Excipients with known effect: Lactose monohydrate 50.35 mg. Inactive ingredients: Croscarmellose sodium, anhydrous calcium hydrogen phosphate, Povidone (PVP K30), Crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, macrogol, purified talc, titanium dioxide, and indigo carmine lake. Description: Biolegam 100/60 mg is a combination of sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor, and dapoxetine, a selective serotonin reuptake inhibitor (SSRI). The product is designed for adult men aged 18–64 years who suffer from both erectile dysfunction (ED) and premature ejaculation (PE). It helps to improve erectile function and increase the intravaginal ejaculatory latency time, supporting better control and sexual satisfaction. Biolegam should be used only under medical supervision and only when prescribed by a specialized physician. Indications for Use: Biolegam is indicated for the on-demand treatment of premature ejaculation in men with concurrent erectile dysfunction who meet all of the following criteria: - Intravaginal ejaculatory latency time less than two minutes. - Persistent or recurrent ejaculation with minimal stimulation before or shortly after penetration. - Marked distress or interpersonal difficulty caused by PE. - Poor control over ejaculation. - History of PE for at least six months. Dosage and Method of Administration: - The recommended starting dose is 50 mg Sildenafil / 30 mg Dapoxetine, taken as needed approximately 1 hour before sexual activity. - Treatment should not be initiated with 100/60 mg. - If the 50/30 mg dose is well tolerated but ineffective, the dose may be increased to 100/60 mg as prescribed. - Do not take more than one tablet within 24 hours. - Not intended for continuous daily use. - Take the tablet with at least one full glass of water, with or without food. - Biolegam should be used only when sexual activity is anticipated. Contraindications: - Biolegam is contraindicated in patients with: - Hypersensitivity to sildenafil, dapoxetine, or any excipient. - Severe cardiovascular disease (e.g., heart failure, unstable angina, conduction abnormalities). - Moderate or severe hepatic impairment (Child-Pugh B or C). - History of mania, severe depression, or syncope. - Use of nitrates, nitric oxide donors, or guanylate cyclase stimulators (e.g., riociguat). - Concomitant use of potent CYP3A4 inhibitors (ketoconazole, ritonavir, itraconazole, etc.). - Concomitant use of MAO inhibitors, SSRIs, SNRIs, TCAs, thioridazine, or serotonergic herbal products (e.g., St. John’s Wort). - Men for whom sexual activity is inadvisable due to cardiovascular risk. - Anatomical penile deformities or predisposition to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia). - Severe renal impairment. Precautions: - Syncope and Orthostatic Hypotension: May occur suddenly with or without warning symptoms such as dizziness or nausea. Rise slowly from sitting or lying positions. - Cardiovascular risk: Sildenafil causes mild, transient decreases in blood pressure; use caution in patients with heart disease. - Concomitant use with alcohol or recreational drugs may increase risk of dizziness, fainting, and accidents. - Drug interactions: Use caution with alpha-blockers, CYP2D6 and moderate CYP3A4 inhibitors. - Psychiatric conditions: Do not use in men with untreated depression or bipolar disorder. - Seizure risk: Avoid in patients with unstable epilepsy. - Vision changes: Stop use immediately if sudden visual defect occurs. - Priapism: Seek medical help if erection lasts longer than 4 hours. - Not intended for women or individuals under 18 years of age. - Avoid grapefruit juice within 24 hours of taking Biolegam. - Use only under specialist supervision; not for long-term continuous use. Side Effects: Very common: Headache, nausea, dizziness. Common: Flushing, nasal congestion, diarrhea, insomnia, fatigue, blurred vision. Uncommon: Orthostatic hypotension, syncope, palpitations, vomiting, anxiety, dry mouth, tinnitus. Rare: Priapism, chest pain, hypersensitivity reactions, sudden hearing loss, severe skin reactions (Stevens-Johnson syndrome). Most side effects are mild to moderate and transient. Pregnancy and Lactation: Biolegam is not indicated for use by women. There is no evidence of effect on sperm motility or morphology after single doses of sildenafil 100 mg. Storage Conditions: Store below 30°C in a dry place. Keep out of reach of children. Packaging: Carton box containing 2 strips, each with 4 film-coated tablets and a package insert.